What is Keytruda?

Keytruda (pembrolizumab) is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

Keytruda is used to treat:

• advanced skin cancer (melanoma) that has spread to other parts of the body or cannot be surgically removed;
• a certain type of non-small cell lung cancer, if your tumor has a specific genetic marker for which your doctor will test;
• head and neck cancer that has spread to other parts of the body, or has come back after prior treatment;
• classical Hodgkin lymphoma in adults and children;
• a certain type of bladder and urinary tract cancer that has spread to other parts of the body or cannot be surgically removed; and
• a type of cancer that laboratory testing proves to be a microsatellite instability-high or a mismatch repair deficiency solid tumor.

Keytruda is often given after other cancer medicine has been tried without success.

Keytruda was approved by the US Food and Drug Administration (FDA) on an “accelerated” basis to treat lung cancer or head and neck cancer. In clinical studies, tumors responded to this medicine. However, it has not been shown that pembrolizumab can improve symptoms or lengthen survival time.

Important information

Keytruda can change the way your immune system works, which may cause certain side effects that can lead to serious medical problems.

Call your doctor at once if you have: chest pain, cough, shortness of breath, vision changes, tiredness, severe muscle pain or weakness, diarrhea and severe stomach pain, blood in your stools, bruising or bleeding, dark urine, yellowing of the skin or eyes, a hormonal disorder (frequent headaches, feeling light-headed, rapid heartbeats, a deeper voice, increased thirst or urination, feeling cold, weight gain or loss), or a change in the amount or color of your urine.

The side effects of Keytruda can cause symptoms in many different parts of your body. Some side effects may need to be treated with other medicine, and your cancer treatments may be delayed. You will need frequent medical tests to help your doctor determine if it is safe for you to keep receiving Keytruda. Do not miss any follow-up visits to your doctor.

Before taking this medicine

To make sure Keytruda is safe for you, tell your doctor if you have:

• a lung disease or a breathing disorder;
• liver or kidney disease;
• a thyroid disorder;
• an autoimmune disorder such as lupus, Crohn’s disease, or ulcerative colitis; or
• if you have ever had an organ transplant.

Do not use Keytruda if you are pregnant. It could harm the unborn baby. Tell your doctor right away if you become pregnant during treatment. Use effective birth control while you are using this medicine and for at least 4 months after your last dose.

It is not known whether pembrolizumab passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using Keytruda and for at least 4 months after your last dose.

How is Keytruda given?

Keytruda is injected into a vein through an IV. A healthcare provider will give you this injection.

Keytruda is usually given once every 3 weeks. Your doctor will determine how long to treat you with this medicine. Follow your doctor’s dosing instructions.

Before you start treatment, your doctor will perform tests to make sure Keytruda is the best treatment for your type of skin cancer.

Keytruda can cause certain side effects by changing the way your immune system works. These side effects can cause symptoms in many different parts of your body. Some side effects may need to be treated with other medicine, and your cancer treatments may be delayed or stopped altogether.

You will need frequent medical tests to help your doctor determine if it is safe for you to keep receiving Keytruda. Do not miss any follow-up visits to your doctor.

Keytruda dosing information

Usual Adult Dose for Melanoma – Metastatic:

2 mg/kg IV infusion over 30 minutes

Duration of therapy: Administer every 3 weeks until disease progression or unacceptable toxicity.

Uses: Treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and a BRAF inhibitor if BRAF V600 mutation positive.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your Keytruda injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while receiving Keytruda?

Keytruda can pass into body fluids (urine, feces, vomit). For at least 48 hours after you receive a dose, avoid allowing your body fluids to come into contact with your hands or other surfaces. Caregivers should wear rubber gloves while cleaning up a patient’s body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Keytruda side effects

Get emergency medical help if you have any signs of an allergic reaction to Keytruda: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your caregiver right away if you feel dizzy, light-headed, itchy, hot or cold, sweaty, tingly, feverish, or if you have trouble breathing.

Keytruda can change the way your immune system works, which may cause certain side effects that can lead to serious medical problems.

Call your doctor at once if you have:

• new or worsening cough, chest pain, feeling short of breath;
• pale skin, easy bruising or bleeding;
• severe muscle weakness, severe or ongoing muscle aches, joint pain;
• diarrhea or increased stools, severe stomach pain, stools that contain mucus, black/bloody or tarry stools;
• low levels of sodium in the body – confusion, slurred speech, severe weakness, loss of coordination, feeling unsteady;
• signs of a hormonal disorder – frequent or unusual headaches, vision problems, feeling light-headed or very tired, rapid heartbeats, mood or behavior changes, hoarse or deepened voice, increased hunger or thirst, increased urination, constipation, hair loss, sweating, feeling cold, weight gain, or weight loss;
• symptoms of a kidney problem – urinating more or less than usual, pelvic pain, vomiting, swelling in your ankles or feet, pain or burning when you urinate, bloody or cloudy urine; or
• liver problems – loss of appetite, right-sided stomach pain, easy bruising or bleeding, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common Keytruda side effects may include:

• nausea, vomiting, stomach pain, loss of appetite, diarrhea, constipation;
• low sodium levels, abnormal liver function tests;
• itching or rash;
• fever, cough, feeling short of breath;
• pain in your muscles, bones, or joints; or
• feeling tired.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Keytruda?

Tell your doctor about all your current medicines and any you start or stop using, especially:

• dexamethasone with thalidomide.

This list is not complete. Other drugs may interact with pembrolizumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.